Data / Medical devices / Japan / Tanita Corp.

Tanita Corp.: FDA-registered device maker in ITABASHI-KU Tokyo, Japan, 8 510(k) clearances

Name: Tanita Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tanita Corp. is registered with the FDA (registration 9680010) in ITABASHI-KU Tokyo, Japan. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 15, 2011. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Tanita Corp.

FDA registration number: 9680010
FEI number: 1000419277
Address: 14-2, 1-Chome, Maeno-Cho, ITABASHI-KU Tokyo, Japan, 174-8630
Owner or operator: TANITA CORP. OF AMERICA (9006383)
Roles: Specification developer
First device listed: January 31, 1994
Registered through: 2026
Brand names listed: BC-1500PRO, BC-401F, BC-603FS, DC-13C, DC-240, DC-240IM, MC-580, MC-780U PLUS P and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition	MNW	2	Specification developer	accessdata.fda.gov
Analyzer, Body Composition, Exempt	PUH	2	Specification developer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Specification developer	accessdata.fda.gov
Scale, Patient	FRW	1	Specification developer	accessdata.fda.gov
Scale, Stand-On, Patient	FRI	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 15, 2011	K100183	MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER	MNW	Substantially Equivalent	Tanita Corp.	accessdata.fda.gov
July 7, 2009	K090479	TANITA BODY COMPOSITION ANALYZER, MODEL SC-331	MNW	Substantially Equivalent	Tanita Corporation of America	accessdata.fda.gov
December 28, 2006	K062652	INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR	MNW	Substantially Equivalent	Tanita Corporation of America	accessdata.fda.gov
December 23, 2004	K040778	TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)	MNW	Substantially Equivalent	Tanita Corp. of America	accessdata.fda.gov
July 22, 2004	K040978	TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE	MNW	Substantially Equivalent	Tanita Corp. of America	accessdata.fda.gov
April 8, 2004	K033157	TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418	MNW	Substantially Equivalent	Tanita Corp. of America	accessdata.fda.gov
June 24, 2002	K014009	TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE	MNW	Substantially Equivalent	Tanita Corp. of America	accessdata.fda.gov
November 1, 1994	K930599	BODY FAT ANALYZER MODEL TBF-105	DSB	Substantially Equivalent	Tanita Corp. of America	accessdata.fda.gov

Compare with other makers

Updated April 15, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.